The present invention relates generally to the field of biochemical analysis, and in particular to a novel cartridge for conducting a chemical reaction.
The analysis of clinical or environmental fluids generally involves a series of chemical, optical, electrical, mechanical, or thermal processing steps on the fluid samples. In recent years, there has been growing interest in developing disposable cartridges for conducting analyses of biological samples for various diagnostic and monitoring purposes. For example, U.S. Pat. No. 5,587,128 to Wilding discloses devices for amplifying a preselected polynucleotide in a sample by conducting a polynucleotide amplification reaction. U.S. Pat. No. 5,922,591 to Anderson et al. describes a miniaturized, integrated nucleic acid diagnostic device and system. The device is generally capable of performing one or more sample acquisition and preparation operations, in combination with one or more sample analysis operations.
Despite these advances, however, there remains a need for a cartridge that permits the rapid thermal processing of a reaction mixture as well as increased sensitivity in the detection of analyte in the mixture.
The present invention provides an apparatus and method for analyzing a fluid sample to determine the presence or absence of an analyte in the sample. The apparatus includes a cartridge for separating a desired analyte from the sample and for holding the analyte for a chemical reaction and optical detection. The apparatus also includes an instrument for receiving the cartridge for sample processing. The desired analyte may comprise, e.g., organisms, cells, proteins, nucleic acid, carbohydrates, virus particles, bacteria, chemicals, or biochemicals. In a preferred use, the desired analyte comprises nucleic acid and the chemical reaction performed is nucleic acid amplification using, e.g., the polymerase chain reaction (PCR).
In accordance with an aspect of the present invention, a device for conducting a chemical reaction comprises a body having at least first and second channels formed therein. A reaction vessel extends from the body, the reaction vessel having a reaction chamber, an inlet port connected to the reaction chamber via an inlet channel, and an outlet port connected to the reaction chamber via an outlet channel. The inlet port of the vessel is connected to the first channel in the body, the outlet port of the vessel is connected to the second channel in the body, and the body further includes a vent in fluid communication with the second channel for venting gas from the second channel.
In accordance with another aspect of the present invention, a device for conducting a chemical reaction comprises a body having at least first and second channels formed therein. A reaction vessel extends from the body, the reaction vessel having a rigid frame defining side walls of a reaction chamber, first and second polymeric films attached to opposite sides of the rigid frame to form opposing major walls of the reaction chamber, an inlet port connected to the reaction chamber via an inlet channel, and an outlet port connected to the reaction chamber via an outlet channel. The inlet port of the vessel is connected to the first channel in the body, and the outlet port of the vessel is connected to the second channel in the body.
In accordance with another aspect of the present invention, a device for conducting a chemical reaction comprises a body having a sample flow path and having a separation region in the sample flow path for separating a desired analyte from a fluid sample. A reaction vessel extends from the body, the reaction vessel having a reaction chamber, an inlet port connected to the reaction chamber via an inlet channel, and an outlet port connected to the reaction chamber via an outlet channel. The body further has at least first and second channels formed therein, the separation region being connected to the inlet port of the vessel via the first channel in the body, and the outlet port of the vessel being connected to the second channel in the body.
In accordance with another aspect of the present invention, a device for conducting a chemical reaction comprises a body having at least first and second channels formed therein. A reaction vessel extends from the body, the reaction vessel having a plurality of walls defining a reaction chamber. At least one of the walls comprising a flexible sheet or film. The vessel also has an inlet port connected to the reaction chamber via an inlet channel and an outlet port connected to the reaction chamber via an outlet channel. The inlet port of the vessel is connected to the first channel in the body, and the outlet port of the vessel is connected to the second channel in the body. The device also comprises at least one thermal surface for contacting the sheet or film, means for increasing the pressure in the reaction chamber, wherein the pressure increase in the chamber is sufficient to force the sheet or film to conform to the thermal surface, and at least one thermal element for heating or cooling the surface to induce a temperature change in the chamber.
In accordance with another aspect of the present invention, a device for conducting a chemical reaction comprises a body having at least first and second channels formed therein. A reaction vessel extends from the body, the reaction vessel having a reaction chamber defined by two opposing major walls and side walls connecting the major walls to each other. At least two of the walls defining the reaction chamber are optically transmissive. The reaction vessel also has an inlet port connected to the reaction chamber via an inlet channel and an outlet port connected to the reaction chamber via an outlet channel. The inlet port of the vessel is connected to the first channel in the body, and the outlet port of the vessel is connected to the second channel in the body. The device also comprises optics for optically interrogating the reaction chamber, the optics comprising at least one light source for transmitting light to the reaction chamber through a first one of the optically transmissive walls and at least one detector for detecting light exiting the chamber through a second one of the optically transmissive walls.
Another aspect of the invention is a method for conducting a chemical reaction, the method comprising the step of introducing a sample into a device comprising, a body having a sample flow path and having a separation region in the sample flow path for separating a desired analyte from the sample. The device also comprises a reaction vessel extending from the body, the reaction vessel having a reaction chamber, an inlet port connected to the reaction chamber via an inlet channel, and an outlet port connected to the reaction chamber via an outlet channel. The body further has a first channel connected to the inlet port of the vessel and a second channel connected to the outlet port of the vessel. The method also comprises the steps of separating the analyte from the sample in the separation region, forcing the analyte to flow into the reaction chamber of the vessel via the first channel in the body while air displaced from the reaction chamber exits through the outlet channel and outlet port of the vessel into the second channel in the body, and conducting a chemical reaction in the reaction chamber.